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0.0 - 1.0 years
2 - 5 Lacs
Hyderabad/Secunderabad, Pune, Bengaluru
Work from Office
Should have knowledge in clinical research studies Monitoring of Clinical studies conducted at various CROs located globally as per ICH/GCP, applicable regulatory requirements, protocols and SOPs. Perform Site visits (i.e. Site Selection Visit) Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.
Posted 2 months ago
0.0 - 1.0 years
2 - 5 Lacs
Hyderabad/Secunderabad, Pune, Bengaluru
Work from Office
Should have knowledge in clinical research studies Monitoring of Clinical studies conducted at various CROs located globally as per ICH/GCP, applicable regulatory requirements, protocols and SOPs. Perform Site visits (i.e. Site Selection Visit) Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.
Posted 2 months ago
0.0 - 1.0 years
2 - 5 Lacs
Hyderabad/Secunderabad, Pune, Bengaluru
Work from Office
Should have knowledge in clinical research studies Monitoring of Clinical studies conducted at various CROs located globally as per ICH/GCP, applicable regulatory requirements, protocols and SOPs. Perform Site visits (i.e. Site Selection Visit) Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.
Posted 2 months ago
2.0 - 5.0 years
25 - 35 Lacs
Bareilly
Work from Office
Job description Role & responsibilities Clinical Practice: Performing comprehensive examinations and diagnosing diseases. Managing a variety of conditions including their body parts Performing surgical procedures related to their area of expertise. Consulting with other healthcare professionals on complex cases. Teaching and Education: Delivering lectures and seminars to medical students and residents on their specific topics. Supervising residents and fellows in clinical practice and surgical procedures. Designing and implementing curriculum Mentoring junior faculty members Research: Conducting clinical research studies related to diseases and treatments Writing research papers and presenting findings at conferences Securing research funding Administrative Duties: Participating in departmental meetings and committees Contributing to quality improvement initiatives Serving on hospital or university committees Interested Candidates can directly visit to Office at SRMS Hospital HR department, or connect on mail at ashishhr@srmsims.ac.in.
Posted 2 months ago
5.0 - 10.0 years
10 - 15 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
Hi We are Hiring for the job role of Medical Writer Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound, compliant with industry guidelines, and aligned with the target audiences needs. Attention to detail, strong writing skills, and a solid understanding of medical terminology and research practices are essential in this role. Key Skills: a) Minimum 1 Year experience in - eCTD / NEES / Docubridge b) Should have Experience in making Clinical Study Report and Clinical Summary of Safety c) Any Life Science Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 396 Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required
Posted 2 months ago
6.0 - 11.0 years
10 - 15 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
Hi We are Hiring for the job role of Medical Writer Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound, compliant with industry guidelines, and aligned with the target audiences needs. Attention to detail, strong writing skills, and a solid understanding of medical terminology and research practices are essential in this role. Key Skills: a) Minimum 1 Year experience in - eCTD / NEES / Docubridge b) Should have Experience in making Clinical Study Report and Clinical Summary of Safety c) Any Life Science Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 396 Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required
Posted 2 months ago
4.0 - 9.0 years
10 - 15 Lacs
Mumbai Suburban, Pune, Mumbai (All Areas)
Work from Office
Hi, We are hiring for Leading ITES Company for Medical Writer Profile. Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound, compliant with industry guidelines, and aligned with the target audiences needs. Attention to detail, strong writing skills, and a solid understanding of medical terminology and research practices are essential in this role. Key Skills: a) Minimum 1 Year experience in - eCTD / NEES / Docubridge b) Should have Experience in making Clinical Study Report and Clinical Summary of Safety c) Any Life Science Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 Role & Responsibilities: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required
Posted 2 months ago
4.0 - 9.0 years
10 - 15 Lacs
Mumbai, Pune, Mumbai (All Areas)
Work from Office
Hi Hiring for the leading ITES Company for Regulatory Medical Writer Profile. Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound, compliant with industry guidelines, and aligned with the target audiences needs. Attention to detail, strong writing skills, and a solid understanding of medical terminology and research practices are essential in this role. Key Skills: a) Minimum 1 Year experience in - eCTD / NEES / Docubridge b) Should have Experience in making Clinical Study Report and Clinical Summary of Safety c) Any Life Science Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required
Posted 2 months ago
3.0 - 5.0 years
0 Lacs
Maharashtra, India
On-site
Job Description This role is for a full-time Consultant for the Quantitative Pharmacology and Pharmacometrics group (QPP) in Cytel. You will be responsible for non-compartmental pharmacokinetics analyses, QC and programming within QPP. Responsibilities Performing and QC and interpretation of non-compartmental pharmacokinetics (PK) analyses, including data formatting Contribution to the PK portion of Statistical Analysis Plans Interfacing with other departments within Cytel, including PBS and FSP. Meeting with clients, as needed Contributing to reports and slide decks Ensuring all analyses are performed under the appropriate standard operating procedures Archiving of all data and analyses Qualifications B.S. or M.S. in pharmacy, biology, chemistry, data science or a related scientific discipline. 3-5 years' experience in the pharmaceutical industry Basic knowledge of pharmacokinetics Must demonstrate proficiency in R programming Experience with WinNONLIN is strongly preferred Show more Show less
Posted 2 months ago
5.0 years
0 Lacs
Ahmedabad, Gujarat, India
On-site
Job Title: Lead Medical Writer Company Overview ( https://www.tatvacare.in/) Tatvacare is a cutting-edge digital health company based out of Ahmedabad, Bangalore and New Delhi. We provide comprehensive technology solutions that enhance the interactions between patients and doctors, leading to significantly improved health outcomes. With a focus on innovation and service, Tatvacare is poised for rapid growth due to its focused new age digital health tech products. Purpose of position: The Lead Medical and Scientific Writer is responsible for developing and reviewing high-quality medical content, including scientific publications- Original research articles, Consensus, Expert Opinions, Review Articles, Meta-analysis, Case reports and series, Narratives, clinical trial documentation, regulatory submissions, and real-world evidence (RWE) reports. This role involves collaborating with cross-functional teams, providing scientific expertise, and ensuring compliance with regulatory and industry standards. The ideal candidate will have extensive medical writing experience, particularly in clinical development, regulatory affairs, and digital health research. Responsibilities: 1. Medical Writing Strategy: Document Preparation, Development and Finalization/Document Management/Review • Help evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects. • Plan, review, coordinate and complete the publication of scientific data in peer-reviewed journals and forums. • Conduct effective document initiation via a kick-off meeting to ensure authoring team alignment and understanding. • Coordinate expert/scientific reviews, collate reviewer’s comments, adjust content of document as required based on internal/external input, and prepare final version. • Ensure and coordinate quality checks for accuracy 2. Project and Stakeholder management •Lead the writing process and apply effective project management skills to ensure timely completion of high-quality scientific publication deliverables. •Build/Communicate credible writing project timelines. •Anticipate and mitigate risks to delivery. •Work with teams and stakeholders to ensure smooth and timely development of documents and escalate issues, as appropriate, to ensure document completion. •Effectively communicate project status to stakeholders. 3. Knowledge Sharing • Provide guidance to the team in review and writing of various scientific documents. • Continuous Improvement & Feedback Mechanism • Training & Mentoring the Medical Writing Team • Compliance with Journal or Regulatory Guidelines • Recognized for technical expertise in specific document development. • Contribute to process improvements, suggesting opportunities where appropriate. • Provide database and other tool (e.g., document management systems) expertise Minimum Qualification Requirements: • Advanced degree in a life sciences discipline (Medicine, Pharmacology, Biochemistry, Biotechnology, Public Health, or related fields). • Experience in writing scientific publications. • Strong communication and interpersonal skills. Other Information/Additional Preferences: Experience & Skills: • 5+ years of experience in medical and scientific writing within pharmaceutical, healthcare, CRO, or digital health domains. • Strong experience in writing scientific publications, regulatory documents, and clinical trial reports. • Expertise in real-world evidence (RWE) research, systematic reviews, and meta analyses and other scientific publications. • Proficiency in statistical interpretation and collaboration with biostatisticians. • Demonstrated ability to publish in peer-reviewed journals and present at conferences. • High proficiency in English (verbal & written), with strong attention to detail and scientific accuracy. • Ability to work under strict timelines and manage multiple projects efficiently. Technical Proficiency: • Expertise in Microsoft Office Suite (Word, Excel, PowerPoint). • Experience with reference management tools (EndNote, Zotero, Mendeley). • Familiarity with statistical analysis software (SPSS, SAS, R) for data interpretation Other Preferred Skills & Attributes: Previous experience in: • Health Economics & Outcomes Research (HEOR) • Adherence to ICMJE, CONSORT, PRISMA, and GPP guidelines. • Compliance with the target journal’s author instructions (word limit, reference style, formatting). • Ethical considerations such as disclosures, conflicts of interest, and authorship criteria. • Developing patient-centric materials and healthcare communication strategies Soft Skills: • Strong leadership, strategic thinking, and mentorship abilities. • Ability to synthesize complex clinical data into clear and concise scientific writing. • Excellent communication & stakeholder management skills Show more Show less
Posted 2 months ago
0.0 years
0 Lacs
Andheri, Mumbai, Maharashtra
On-site
Position: Pharmacist Company Website: https://onehealthassist.com/ Company LinkedIn: https://in.linkedin.com/company/one-health-assist Working time: Monday-Saturday between 10AM-7PM-(Onsite) Location:- Andheri West, Mumbai, Maharashtra 400102 About Company - One Health Assist is a Consumer Tech Platform in Health & Wellness. OHA is committed to redefining Health & Wellness by placing individuals at the forefront. Our platform is expertly crafted to meet specific needs, offering a seamless and integrated health & wellness experience that emphasizes personalized care and comprehensive support. Position Summary: We are seeking a Pharmacist to join our growing Health and Wellness company. This role goes beyond traditional dispensing and focuses on empowering clients to lead healthier lives through education, medication management, and integrative wellness support. You will collaborate with other health professionals to deliver personalized care and promote overall well-being. Key Responsibilities: Medication Management: Dispense prescription medications accurately, counsel clients on usage, side effects, and interactions, and ensure compliance with all regulations. Wellness Consultations: Provide guidance on over the counter (OTC) health products, supplements, and lifestyle choices to support holistic wellness. Client Education: Deliver clear, empathetic education on chronic disease management, medication adherence, nutrition, and general health. Collaborative Care: Work with healthcare providers, nutritionists, and wellness coaches to support comprehensive care plans. Health Screenings: Administer or assist with services such as blood pressure checks, immunizations, and health risk assessments (as applicable). Qualifications: Doctor of Pharmacy (Pharm.D.) degree from an accredited institution. Active state pharmacist license in good standing. Strong knowledge of pharmacology, integrative medicine, and OTC products. Passion for preventive care and a holistic approach to health. Excellent communication and interpersonal skills. Experience in retail, clinical, or wellness settings preferred Thanks & Regards Amisha Shelar Contact: 885-057-2613 Email: amisha@onehealthassist.com Job Type: Full-time Benefits: Provident Fund Schedule: Rotational shift Application Question(s): What is your Current CTC? What is your official notice period? What is your work experience? Do you have a license for the pharmacist? Are you comfortable to work in a night shift? Work Location: In person
Posted 2 months ago
1.0 - 3.0 years
0 Lacs
Mumbai Metropolitan Region
On-site
Your Tasks And Responsibilities Core scientific member of cross-functional franchise team and a disease area expert, responsible for scientific enablement of respective business cluster Conceptualization and project management of wide range of medical activities that are aligned to the respective franchise strategy like: New Product Ideation New Product Evaluation Therapeutic rationale & relevant Medical support for regulatory submissions Preparation of SEC presentations & defense in SEC meeting Pre-launch & launch preparations including product monograph, training manuals, training & CME slides Franchise Medical Education programs Promotional and non-promotional material review & approval Answering queries Marketing and Sales training Real World Clinical Research and Publications – Planning and Execution Advisory board meetings Developing Insight driven Medical Plans Interaction & Engagement of identified Key Opinion leaders in a peer-to-peer capacity through medical affairs activities, in alignment with the overall strategic plan to shape disease areas of interest A therapeutic area scientific expert, responsible for discussing the scientific data pertaining to products on proactive and reactive basis, obtain insights into patients’ treatment trends and insights in the disease areas of interest and to be considered a trusted scientific counterpart Responsible for identifying knowledge gaps, practice gaps and data gaps and provide recommendations for devising medical & product education programs, evidence generation and special projects Ability to convert insights on disease trends and treatment patterns from KOLs into viable and formidable solutions to shape the therapeutic areas of interest Devise optimal training plan to ensure flow of latest medical developments in the given to sales & marketing team Jointly responsible with marketing teams to support optimal patient outcomes through communication of data, information, and insights to shape disease areas of interest Represent the organization in various internal & external scientific platforms Collaborate with thought leaders to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in journals of repute Receiving and processing scientific information requests received from physicians & internal stakeholders Ability to handle complex questions from health care professionals related to company products or disease area to satisfaction Responsible for ensuring that all promotional materials are approved within stipulated timelines and in alignment with company approval process Conduct of robust medical evaluation of new products through thorough desk research and interactions with KOLs Who You Are Education: MD (Pharmacology) Experience: 1-3 years working experience in the pharmaceutical industry or research company in a capacity of HO Medical Advisor or Sr. Medical Advisor Training in medical writing, clinical trial methodologies, research design and ICH – GCP will be added advantage Must have working knowledge of Indian regulations pertaining to Health care professionals’ interactions (MCI code of ethics for doctors & UCPMP Code for Pharma) and Drugs and Cosmetic Act regulations pertaining to clinical trials and new drug approvals Strong academic record with deep knowledge of the therapeutic area, strength in research with knowledge of research methodologies and interpretation of medical data Strategic mindset with scientific acumen and communication skills in order to be accepted by leading specialists in peer-to-peer capacity Experience with complex business environments preferred Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and award Job Location: Sun House, Goregaon East, Mumbai Show more Show less
Posted 2 months ago
1.0 - 3.0 years
2 - 6 Lacs
Bengaluru
Work from Office
Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Bachelor in Physiotherapy/BSc. Nursing Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Ability to work well in a team Adaptable and flexible Agility for quick learning Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualifications Bachelor of Pharmacy,Bachelor in Physiotherapy,BSc. Nursing
Posted 2 months ago
2.0 - 4.0 years
0 Lacs
Bengaluru, Karnataka, India
On-site
PURPOSE Performs and oversees data management activities in order to provide high quality data that meets client/project needs. Ensures that data is processed and tracked in alignment with regulatory and quality standards. Responsibilities Serve as main point of contact for Data Management for 5 to 10 studies, or serve in a leadership role to a specific DM Task. Manage delivery of projects through full eCOA data management study life-cycle. Manage eCOA DM project timelines and quality; determine resource needs; identify out-of-scope work. Perform comprehensive data management tasks including data review, writing and resolving data clarifications. Provide support in database design activities for technologies not requiring extensive programming. Perform comprehensive quality control procedures. Independently bring project solutions to the eCOA team. Solve issues through using the global issue escalation/communication plan. Consult with eCOA ops Group for process issues; communicate ideas for process improvement. Assist in developing and implementing new technology. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with eCOA team. Interact with other study team members to negotiate timelines and responsibilities. Required Knowledge, Skills And Abilities Good understanding of clinical drug development process and Data Management activities. Background in, medical terminology, Pharmacology, Anatomy, and Physiology. Excellent organizational, communication, and data management skills (detailed oriented). Ability to establish and maintain effective working relationships with coworkers, managers and clients. Ability to work within a team and with a good level of autonomy. Minimum Required Education And Experience Bachelor’s degree, or educational equivalence, in clinical, biological, or mathematical sciences or related field or nursing qualification with 2-4 year clinical trials experience in function similar to DM; or equivalent combination of education, training and experience. Physical Requirements Extensive use of telephone and face-to-face communication requiring accurate perception of speech Extensive use of keyboard requiring repetitive motion of fingers Regular sitting for extended periods of time IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com Show more Show less
Posted 2 months ago
2.0 - 7.0 years
15 - 30 Lacs
Meerut
Work from Office
Urgent vacancies for Teaching Faculties SR, AP, Associate & Professor with good experience in medical college at a medical college in Meerut, UP Salary as per industry Norms,
Posted 2 months ago
1.0 - 6.0 years
10 - 15 Lacs
Bangalore Rural, Bengaluru
Work from Office
Hi, We are hiring for the Leading ITES Company for Medical Writing Role. Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound, compliant with industry guidelines, and aligned with the target audiences needs. Attention to detail, strong writing skills, and a solid understanding of medical terminology and research practices are essential in this role. Key Skills: a) Min 1 Year Experience in Clinical Study and Summary Writing Common Technical Document. b) Should have Experience in making Clinical Study Pharmacology Report, Clinical Study Report and Clinical Summary of Safety c) Any Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Bangalore ) Type : Job Code # 396 Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required
Posted 2 months ago
0 years
0 - 0 Lacs
India
On-site
An Assistant Professor of Pharmaceutical Sciences typically combines teaching, research, and service responsibilities within a college or university. They are expected to teach undergraduate and graduate courses in pharmaceutical sciences, conduct research, publish scholarly articles, and supervise student research projects. Additionally, they participate in departmental activities, contribute to curriculum development, and may seek external research funding. Key Responsibilities: Teaching: Delivering lectures, conducting laboratory sessions, and developing course materials for undergraduate and graduate courses in areas like pharmaceutics, biopharmaceutics, pharmacokinetics, and drug delivery. Research: Conducting independent or collaborative research, publishing findings in peer-reviewed journals, and seeking external funding for research projects. Service: Participating in departmental committees, advising students, mentoring other faculty, and representing the college or university in professional organizations. Curriculum Development: Contributing to the development and improvement of existing courses and curriculum. Student Mentorship: Advising undergraduate and graduate students, supervising research projects, and providing guidance on academic and professional development. Qualifications: Education: M. Pharm. (Pharmacology) and Ph.D. in Pharmaceutical Sciences or a related field. Experience: Demonstrated research experience, teaching experience, and potentially postdoctoral research experience. Freshers can also apply. Skills: Strong communication, interpersonal, and organizational skills, along with the ability to work collaboratively and independently. Salary : As Per Norms Job Type: Full-time Pay: ₹50,000.00 - ₹65,000.00 per month Benefits: Health insurance Provident Fund Schedule: Fixed shift Work Location: In person
Posted 2 months ago
2.0 - 3.0 years
0 - 0 Lacs
Bhubaneshwar
On-site
Job Description: Position Overview: Statesman Academy of Medical Science is seeking a qualified and passionate B. Pharma Lecturer to join our dynamic academic team. The ideal candidate will possess a deep understanding of pharmaceutical sciences, a commitment to student success, and a drive to contribute to the development of future pharmacists. The lecturer will be responsible for teaching undergraduate students in the Bachelor of Pharmacy (B. Pharma) program, delivering engaging lectures, and guiding students in their academic and professional development. Key Responsibilities: Deliver high-quality lectures in B. Pharma courses, ensuring that course content is up-to-date and relevant. Develop and update course materials, including syllabi, lecture slides, assignments, and assessments. Provide academic support to students, including clarifying doubts and offering guidance on projects, assignments, and practical work. Conduct practical demonstrations, laboratory sessions, and clinical simulations where applicable. Stay current with developments in pharmaceutical science and integrate new knowledge into the curriculum. Grade assignments, exams, and other assessments, providing timely and constructive feedback. Organize and participate in academic meetings, workshops, and conferences as required. Participate in departmental activities such as curriculum development, planning, and research initiatives. Foster a positive and inclusive learning environment, encouraging student engagement and participation. Serve as an academic advisor to students, helping them with course selection, career advice, and professional development. Engage in research activities in pharmaceutical science, where applicable, and contribute to academic publications. Qualifications: Master’s degree in Pharmacy (M. Pharma) or a related field (Ph.D. preferred). Minimum of 2-3 years of teaching experience in a pharmaceutical sciences environment, with a focus on B. Pharma programs. In-depth knowledge of pharmaceutical chemistry, pharmacology, pharmaceutics, and other related subjects. Strong communication and presentation skills. Ability to create a stimulating and interactive learning environment. Experience in curriculum development and educational technology integration is a plus. Commitment to academic excellence, continuous professional development, and student success. Skills and Attributes: Strong interpersonal and communication skills. Detail-oriented with excellent organizational skills. Passion for teaching and mentoring students. Ability to work collaboratively with faculty members and staff. Enthusiasm for staying current with industry trends and advancements in pharmacy. Job Types: Full-time, Permanent Pay: ₹25,000.00 - ₹50,000.00 per month Benefits: Paid sick time Provident Fund Schedule: Day shift Fixed shift Work Location: In person
Posted 2 months ago
3.0 years
0 Lacs
Chennai
On-site
Required Assistant Professor/Professor in Pharmacy college, interested can forward the profiles to hrasst2@ssiet.in Qualification : M.Pharm with Ph.D/Pharm.D Pharm.D - ( 3years Exp ) Assistant Professor - Pharmacognosy/Pharmaceutics ( 3 years Exp ) Professor - (Pharmaceutics / Pharmacology/Pharmaceutical Chemistry) - 10+ years Exp Job Location : Poonamallee, Chennai Immediate joiners preferred Job Type: Permanent Schedule: Day shift Application Question(s): What is your current location? Education: Master's (Preferred) Experience: total work 10: 3 years (Preferred) Work Location: In person
Posted 2 months ago
2.0 years
0 Lacs
Hyderabad, Telangana, India
On-site
Summary The Associate Medical Expert in TCO (Translational Clinical Oncology), is the medical leader for assigned global, roll-over and long-term follow-up studies, and studies in the close-out phase. They may also provide medical support for assigned aspects of a global, active, TCO study, under the leadership of a Clinical Program Leader (CPL) and / or Medical Expert TCO (Translational Clinical Oncology) is a department under Biomedical Research division, and is responsible for designing and executing out early phase (first in human) clinical studies in patients with cancer. It acts as a bridge between drug discovery and late phase clinical development and strives to deliver transformative new medicines for oncology conditions. About The Role Major accountabilities: Provides medical support to Clinical Program Leader (CPL) and / or Medical Expert. Medical support may include, but is not limited to, contributing to clinical sections of protocols and/or amendments, Informed Consents, publications, regulatory documents such as Investigator Brochures, responses to Health Authority questions and conducting ongoing review of clinical trial data, with oversight of TCO deliverables. May act as the medical monitor to support overall program safety reporting (e.g., Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety Team. Contributes to clinical/scientific elements of TCO – related submission documents, including preparation and review of project documentation for Health Authority submission, including briefing books, IBs, Annual Safety Reports, responses to Health Authority questions etc. Contributes to the ongoing clinical trial data medical/scientific review across assigned TCO studies and coordinates data analysis and interpretation Supports conduct of dose escalation meetings, investigator teleconferences and site initiation visits etc. Accountable for assigned close-out, roll-over and long-term follow-up studies, ensuring Clinical Study Report review, consistency and quality of clinical study reports (CSR) in collaboration with CSR medical writing team, and publication of studies across assigned TCO projects - either directly as lead author or by providing leadership to the medical writing team Maintains expert knowledge of ICH-GCP, external regulations and procedures, and supplements by training and practice of Novartis SOPs and internal policies. Advocate continuous improvement of quality Key Performance Indicators Evidence of high-quality medical input to assigned studies to ensure execution according to timelines and ensuring adherence to international and local regulations. Evidence of quality medical and scientific review of clinical trial data Demonstrates excellent scientific writing skills to enable the development of high-quality documents including but not limited to clinical trial protocols, trial reporting (e.g. CSR), and regulatory documents (e.g. IB, DSUR). Contribution towards objectives set for the department. Feedback from external and internal stakeholders. Clearly demonstrates Novartis Values and Behaviors. Minimum Requirements MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine / pharmacology etc.) with medical council certification required. Experience in hematology / oncology preferred. Work Experience At least 2 years of pharmaceutical/biotech industry experience or at least 4 years of clinical practice experience in the hospital setting Knowledge of Good Clinical Practice (GCP). Strong operational project experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities. Demonstrated operational excellence and scientific contribution to clinical or preclinical projects. Clear written and verbal expression of ideas, an active/proactive communicator. Well-developed interpersonal skills, with a proven record of accomplishment of successfully interacting with, influencing and building strong positive relationships. Used to working independently and in a team, being flexible and adapting in a changing environment. Skills Clinical Monitoring. Clinical Research. Clinical Trial Protocol. Clinical Trials. Decision Making Skills. Drug Development. Health Sciences. Lifesciences. Regulatory Compliance. Languages English. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less
Posted 2 months ago
0.0 years
0 Lacs
Mumbai Metropolitan Region
On-site
THE POSITION Will be responsible for executing medical affairs strategy in the assigned zone. Tasks & Responsibilities Understand the current practices, medicines being used, and trends in relation to their respective therapeutic area through key customer contacts, attending scientific symposia and reviewing key therapeutic journals in order to provide relevant information to internal and external customers Effectively gathers and disseminates information in a concise and understandable format to both internal and external customers and position BI Medical as a preferred partner for key customers through credible and clear non-promotional communication Execute key medical projects (e.g. IIS studies) to ensure that BI interacts most efficiently with customers and key customer networks through optimal contact, so as to bring significant value to both the customer and BI Participate in the implementation of the local medico marketing strategy Identify the EEs in the territory. Develop relationship with team and network for effective promotion of BI and BI products. Give feedback to the management regularly about KOL development Provide medical and product expertise towards registration of new products/indications with federal/state regulatory authorities through delivery of scientific presentations, provision of medical rationale and published literature, and liaison with key HCPs for obtaining support for new product/indication Provide medical and product expertise towards defense of marketed products (regulators, NGOs, press, etc.) Write, revise, and review labeling documents for pipeline/local products per relevant SOPs Assist regulatory affairs with EE access when appropriate Requirements Education : Medical degree (preferable qualification in Pharmacology), or qualification in Life-science Preferably 0-3 years experience on the same field and Pharmaceutical or Healthcare industry. Beginner level can apply as long as candidate is graduate of MD in Pharmacology. For professional without doctoral qualification, relevant field-based work experience of 10+ years with good scientific expertise is preferable Scientific expertise on diabetes therapy area is required Excellent interpersonal skill Basic IT Knowledge on MS Office applications Role is based in Mumbai READY TO APPLY? Click the “Apply On Company website” button. Create an account or sign in and continue to register your profile, upload your resume, and apply in the company site. For any technical issues or additional questions, contact HR Direct. (Note: resumes should not be submitted to HR Direct since job applications are not processed via email or phone call) HR Direct contact information: Phone: +91-22-7145-6700 Email: HRDirect.PH@boehringer-ingelheim.com Our Company Why Boehringer Ingelheim? With us, you can develop your own path in a company with a culture that knows our differences are our strengths \u2013 and break new ground in the drive to make millions of lives better. Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed. Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after \u2013 as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations. Want to learn more? Visit https://www.boehringer-ingelheim.com Show more Show less
Posted 2 months ago
0.0 - 1.0 years
2 - 3 Lacs
Hyderabad
Work from Office
Perform triage & intake of ICSR received daily in ARGUS databases Should have hands On Experience On ARGUS Safety Database Should Have hands on Experience on MEDDRA Applicants Should Complete Certification in Pharmacoviiglance Required Candidate profile B.Pharm / M.Pharm/Pharm D/Life sciences degree With Hands On Experience On Argus Safety Database and Med DRA coding, Argus, Narrative Writing, Triage Should have good communication Skills
Posted 2 months ago
5.0 years
0 Lacs
Noida, Uttar Pradesh, India
Remote
We are looking for Team Manager Pharmacovigilance to join our team in India on a permanent basis. All over the world, decision-makers depend on us for the essential knowledge that can justify their strategies, promote outstanding research and business growth, and keep them abreast of the market. You’ll join our Life Sciences & Healthcare Pharmacovigilance team responsible for the curation of drug safety information collected from journals, congress publications and drug regulatory approvals which are delivered to OFF-X, a translational drug safety intelligence portal that allows users to easily identify new drug and target safety liabilities. About You – Experience, Education, Skills, And Accomplishments Degree in Life Sciences (Toxicology, Pharmacology, Biology, Pharmacy, Biomedical Sciences, etc.) and experience in pharmacovigilance, drug safety management and/or toxicology At least 5 years’ experience in a global corporation (pharma domain or consulting) with people and process management experience Excellent written and oral communication skills in English. It would be great if you also had . . . Demonstrated ability to work collaboratively in a matrixed organization. Good judgment in decision-making and priority setting. Ability to analyze processes, identify problems, and develop effective solutions. Capability to work remotely with peers in an international environment. Ability to delve deep into content and results. What will you be doing in this role? Create a culture of success, motivating, and developing colleagues to achieve their full potential. Drive execution and performance. Ensure key performance indicators for quality, timeliness and completeness are delivered and strive for continuous improvement. Build a customer-focused team and develop an environment which stimulates innovation. Play a role in major decisions and initiatives to enable the Content Function to achieve its long-term objectives. Communicate initiatives to senior management, set timelines and manage expectations for all deliverables and releases. Work together with Product, Product Operations, Technology and Marketing in the product development process Identify opportunities for synergies and simplification of complex processes. About The Team You’ll be reporting to the Director, Content Editing, based in France and join an international and diverse team of more than 80 colleagues mostly based in Spain and India The OFF-X team is composed of around 20 colleagues mostly based in India The team culture is dynamic, creative, and supportive – excellence, integrity, and care are in our DNA. You’ll have 40 annual paid hours of volunteering time and the chance of being part of an active volunteering community which promotes diversity and inclusion across the business. Hours of Work 40 hours in a week as an FTE Location - Chennai and Noida At Clarivate, we are committed to providing equal employment opportunities for all persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations. Show more Show less
Posted 2 months ago
0.0 - 5.0 years
5 - 12 Lacs
Chennai
Remote
Review and execute physician’s prescriptions checking their appropriateness and legality. Maintain full control over delivering, stocking and labeling medicine and other products and monitor their condition to prevent expiring or deterioration. Required Candidate profile Thorough understanding of dosage administration and measurement, chemical compounds, medical brands etc. Excellent communication skills with a customer oriented approach. Integrity and compassion. Perks and benefits Health insurance Retirement plans Paid time off
Posted 2 months ago
3.0 years
0 Lacs
Hyderabad, Telangana, India
On-site
Role: Associate - Transporters and hepatocytes research (DMPK) Department: DMPK Location: Hyderabad About Us: Sai Life Sciences is one of the fastest-growing Contract Research, Development, and Manufacturing Organizations (CRDMOs). As a pure-play, full-service partner, we collaborate with over 300 global innovator pharma and biotech companies to accelerate the discovery, development, and commercialization of their NCE programs. We have over 3000 employees across our facilities in India, the UK, and the USA, working together to deliver scientific excellence and customer success. We are a Great Place to Work certified organization with a culture of openness, mutual respect, and inclusivity. We embrace diversity and follow equal opportunity practices across all levels. Key Responsibilities : Hands-on experience in conducting transporter uptake and inhibition assays using HEK293 stably transfected cell lines. Prior experience in validation of transporter transfected cell lines and support the customers with customised assay conditions. Experience in conducting the oil spin method for assessing uptake and inhibition. Hands-on experience or ability to conduct CYP450 inhibition studies using hepatocytes. Experience in conducting in vitro transporter assays with radioisotope labelled compounds. Maintenance of cell line inventory and lab infrastructure. Support IND-enabling studies, routine screening, and generate high-quality data. Participation in scientific innovation projects in the field of drug transporters. Familiarity with the extended clearance classification system. Knowledge of data compilation and interpretation for test compound classification systems, either as substrates or uptake inhibitors. Ability to understand and read data, identify data variability, and participate in data review cycles with the QA team. Commitment to delivering data within agreed timelines (< 7 days) and strong work ethics to complete assigned tasks. Excellent communication and collaboration skills, working closely with team members. Good oral and written communication skills. Education and Experience: M Pharm (Pharmacology/Pharmaceutics) with 3-8 years of experience or MSc with 6-8+ years of experience in DMPK of small molecule drug discovery and development, preferably in a CRO or Biotech/Pharma industry. Knowledge of FDA and EMA industry guidance. Show more Show less
Posted 2 months ago
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